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Study on Drug Interactions Affecting the Pharmacokinetics of RSS0343 Tablet

6 de julio de 2026 actualizado por: Reistone Biopharma Company Limited

A Single-center, Single-sequence, Self-controlled Open Design Study , to Investigate the Effects of Rifampicin and Clarithromycin on the Pharmacokinetics of RSS0343.

This study is a single-center, single-sequence, self-controlled, open design, aiming to investigate the effects of rifampicin and clarithromycin on the pharmacokinetics of RSS0343 in humans.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510405
        • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Investigador principal:
          • Dawei Wang
        • Investigador principal:
          • Yan Ling

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  1. The participants voluntarily signed the informed consent form, fully understanding the purpose and significance of this trial and willing to abide by the trial protocol.
  2. Age range: 18 - 55 years old (inclusive of both boundaries), open to both genders.
  3. Male weight ≥ 50 kg, female weight ≥ 45 kg. Body mass index (BMI) = weight (kg) / height² (m²). BMI is within the range of 19 to 28 kg/m² (including the boundary values).
  4. Male and female participants with reproductive capacity, as well as their partners, should have no plans for conception or sperm/egg donation within 6 months (for female participants) or 3 months (for male participants) after the last administration of the drug, and should voluntarily adopt effective contraceptive measures. For female participants with reproductive capacity, the serum pregnancy test must be negative before the first administration of the drug, and they should not be in the lactation period.

Exclusion Criteria:

  1. Those who smoked more than 5 cigarettes per day in the previous 3 months (or used any nicotine-containing products), or those who planned to use any tobacco products during the trial period.
  2. Select individuals who have consumed alcohol frequently within the past 6 months (for women, the daily alcohol intake exceeds 15 g, and for men, it exceeds 25 g [5 g of alcohol is equivalent to 150 mL of beer, 50 mL of wine, or approximately 17 mL of low-alcohol liquor]; and who cannot stop using any alcoholic products during the trial period); or those whose alcohol breath test was positive at baseline.
  3. Those with a history of drug abuse, drug use, drug dependence (during the consultation), or positive results from the baseline urine drug screening.
  4. Within one month before administration, having donated blood or experiencing blood loss of a total volume of ≥ 200 mL, or having donated blood or experienced blood loss of a total volume of ≥ 400 mL within the previous three months; or having received blood transfusion within the previous eight weeks; or having difficulty in venous blood collection, or being physically unable to withstand intensive blood collection.
  5. The researchers believe that participants who have other factors that make them unsuitable to participate in this trial.
  6. The results of physical examination, vital signs, laboratory tests (such as blood routine, urine routine, liver and kidney function, blood biochemistry, coagulation function, thyroid function, etc.), chest imaging, abdominal B-ultrasound and 12-lead electrocardiogram examination, when judged abnormal by the researchers, have clinical significance.
  7. Those who tested positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and HIV antibody.
  8. Suspected of being allergic to the studied drug or any component of the drug, or having a severe allergy to any medication, food, toxin or other exposure.
  9. Any history of severe clinical diseases or conditions that the researcher believes may affect the trial results, including but not limited to diseases of the circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic diseases; or conditions that the researcher believes may affect the research results or affect the absorption, distribution, metabolism and excretion of the drug or expose the participants to inappropriate risks.
  10. Exclude those who have undergone any surgery within the past 3 months, or those who have not fully recovered as determined by the researchers, or those who plan to undergo any surgery during the study period or within 1 month after the study concludes.
  11. Within the first 1 month before the baseline, or within 5 half-lives of the medication (whichever is longer), or during the study period, the use of other CYP3A inducers and inhibitors, any prescription drugs, over-the-counter drugs, including natural health supplements (with the exception of occasional use of paracetamol [up to 2g per day], ibuprofen, or regular use of vitamins) or Chinese herbal medicines.
  12. From 48 hours before the baseline until the end of the study, participants were required to refrain from consuming any beverages or foods containing methylxanthines, such as coffee, tea, cola, chocolate, etc.; from 7 days before the baseline until the end of the study, participants were required to refrain from consuming any beverages or foods containing grapefruit; those with special dietary requirements and unable to follow the unified diet.
  13. Those who received any live vaccine or attenuated live vaccine within the previous 1 month, or those who need to receive a live vaccine during the study period (including 30 days after the last administration of the study drug).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cohort A: Rifampicin Capsules Group
RSS0343 Tablet; Rifampicin Capsules
Experimental: Cohort B: Clarithromycin Tablets Group
RSS0343 Tablet; Clarithromycin Tablets

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Cmax; The maximum plasma concentration
Periodo de tiempo: Day1-Day38
Day1-Day38
AUC0-t; From time 0 to the area under the blood drug concentration-time curve corresponding to the last quantifiable concentration
Periodo de tiempo: Day1-Day38
Day1-Day38
AUC0-inf;Area under the concentration curve from time 0 to extrapolated infinite time
Periodo de tiempo: Day1-Day38
Day1-Day38

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Tmax; Time to maximum plasma concentration
Periodo de tiempo: Day1-Day38
Day1-Day38
t1/2; Terminal half-life
Periodo de tiempo: Day1-Day38
Day1-Day38
CL/F; Apparent clearance
Periodo de tiempo: Day1-Day38
Day1-Day38
Vz/F; Apparent volume of distribution
Periodo de tiempo: Day1-Day38
Day1-Day38
Safety ;Incidence and severity of adverse events
Periodo de tiempo: Day1-Day45
Day1-Day45

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de septiembre de 2026

Finalización del estudio (Estimado)

1 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

6 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

6 de julio de 2026

Publicado por primera vez (Actual)

10 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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